Partnering & Outsourcing Editorial

You did all of the required due diligence. You took the time to select what you felt was the right CRO. You verified its track record, qualifications, and expertise. You even took the time to personally visit the site, to ensure the two companies would share a common culture and commitment to quality. Still, despite all of your efforts, the trial was not going as planned. The last thing anyone wants to do is switch CROs in the middle of a trial. But if you get to the point where making a change is your only option, how do you best accomplish this difficult task?

Alicia McNeil and Elizabeth Kelchner, clinical data scientists for Rho, a full-service CRO, know personally how difficult this task can be. The company has years of experience working on dozens of federal and commercial rescue studies for clients. In their positions at Rho, McNeil and Kelchner are often called upon to resolve issues that arise whenever a clinical study does not go as planned with the CRO originally selected by the sponsor. This experience has taught them how to properly identify the red flags that indicate a study may not be going as planned, and is in need of remediation.

Timothy S. Krupa, MS, MBA, is currently president of TSK Clinical Development, LLC, a consulting firm providing leadership guidance and solutions in the clinical development space. Specifically, Krupa consults on clinical planning, clinical project management, clinical operations, and strategic partnering for the biotech and pharmaceutical industries. Tim recently took some time from his consulting practice to share his perceptions on outsourcing and strategic partnering in the clinical space.

In preparation for the spring 2014 hiring season, The CECON Group has recently developed guidelines for choosing the best consultant for a project. Selecting and managing a technical consultant can be a challenge, especially if the subject matter is well outside of the hiring manager’s field of expertise. In the pharmaceutical industry, consultants can help companies of any size to deal with various aspects of drug development, including the selection of suppliers and outsourcing partners.

It’s rare that I get overly excited about big events. I was pretty calm throughout my wedding (both of them, in fact). I haven’t watched the Super Bowl in about five years, basically due to lack of interest. Ditto for the World Series. I walked out of both The Hangover and Anchorman. When the Royal Wedding was on, I think I shrugged and took a nap.

Ok, maybe I’m exaggerating a bit. But that being said, I am excited about this years’ Partnerships In Clinical Trials show. It could be due to the show being at the beautiful Mirage hotel in Las Vegas. Or perhaps it’s because I will have the opportunity to meet two of my favorite sports idols – Lisa Leslie and Joe Torre. Or maybe it’s due to the prospect of leaving Erie, PA for a warmer climate in late March, which in Erie is still cold, snow, and winter, regardless of what the groundhog or the calendar says. All of those things are probably part of it, but I feel my excitement comes from much more than that.

PwC’s Health Research Institute (HRI) has released a report analyzing the top issues and trends that will impact pharma companies and the health care industry in 2014. Covering everything from the Affordable Care Act to venture capital outlays, the report details the trends and health issues for pharma professionals to watch in the coming year. I spoke with Anup Kharode, director of pharmaceutical R&D advisory services for PwC, about two of those trends, which involve healthcare innovation and clinical trial data/site selection.

Pam Garzone, executive director of biotechnology and clinical development at Pfizer WRD (worldwide research & development), is instrumental in implementing her company’s outsourcing strategy. As the clinical team lead, she is accountable for the clinical development strategy for programs originating at Rinat, a research unit within Pfizer. Her duties include working with different functional expert groups such as biologists, clinicians, both MDs and non-MDs, toxicologists, clinical pharmacologists, and statisticians. “I ensure that everyone on the asset team is in the same boat and rowing in the same direction,” she says.

Challenges in the pharma and biopharmaceutical industries, such as the end of the blockbuster model, the patent cliff, and rising costs, has companies relying more and more on outsourcing partners. In this Women In Bio (WIB) profile article, Laura Marquis, VP, Customer Solutions Management Group at Quintiles, discusses her job, the challenges her clients are facing, and how many of them are best dealing with those challenges. She also discusses what professional women can expect to get out of their affiliation with Women In Bio.

With the cost of a single clinical trial costing upwards of $100 million, it’s not surprising the cost of developing a new drug has risen to more than $1 billion. The rising costs of drug development have personnel at every level of the process seeking ways to cut expenses. A recent collaboration between ViS Research and inVentiv Clinical Trial Recruitment Solutions (iCTRS) seeks to cut the cost of trials by speeding up the process of evaluating and selecting a clinical trial site.

“Pharma and CROs don’t have all of the information they need to properly select the right sites,” says Fabio Thiers, ViS founder and CEO. “As a result, pharma firms and CROs may well end up with centers that don’t recruit any patients, and trials that take twice as long as they should. This lack of available information on trial sites will therefore drive up the cost of trials.”

Sophie McCallum has spent almost four years with clinical solutions firm ClinCapture, currently serving as its director of operations. In this position, McCallum oversees and manages the marketing, HR, finance, and inside sales departments. She also works with the governance team to plan and implement corporate vision and strategy, develops strategic plans and direction for products and services, develops tools and controls to track company profit margins and department budgets, and analyzes business and operation procedures to increase company efficiency and worker productivity. In this Women In Bio profile, McCallum discusses her role in helping build the company, and trends she sees occurring in the clinical research space.